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Manufacturing Engineer

Job Title:

Manufacturing Engineer

 

Reports To:

Manufacturing Engineering Manager

 

The Main Purpose of the Role:

The manufacturing engineer is responsible for providing manufacturing support for existing products and for developing and introducing new products, processes, and equipment.

Key Duties /Responsibilities:

  • Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
  • Develops manufacturing processes and measurement systems to track performances such as scrap and downtime.
  • Develops relevant work instructions and SOP’s and provides guidance to operations on training.
  • Provides guidance to operations regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.
  • Deliver and manage projects within an agreed schedule.
  • Working with internal and external customers and partners to deliver on projects.
  • Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
  • Writing and executing process and equipment validations (IQ/OQ/PQ).
  • Assisting in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment.
  • To meet and/or exceed the Milestones and Goals agreed with the Company.

Experience and Knowledge:

  • Level 8 or higher qualification in Mechanical, Biomedical or related Engineering /Science discipline with good hands-on working knowledge of medical device assembly.
  • Minimum of 4 years of relevant experience in a highly regulated environment, typically Medtech and recent experience in process/validation engineering in a highly regulated environment
  • Broad knowledge of manufacturing processes and systems, techniques, and practices typically gained through extensive experience and/or education.
  • Proven track record in the execution of protocols and validations to regulatory requirements.
  • Successful track record of project managing validation activities and cost reduction projects.
  • Technical knowledge of Automated Systems (Pneumatic, Electro-pneumatic, Robotic).
  • Strong competency in manufacturing processing and systems.
  • Sound technical engineering approach to project management and problem-solving using statical analysis.
  • Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
  • Monitoring of materials, equipment, and process flows during validation and ramp-up related activities to ensure high levels of performance and OEE.
  • Process background (development, capability, optimization, validation) within a regulated industry.
  • A team player who can work effectively and proactively on cross-functional teams. An effective and creative problem solver.
  • Planning and execution of projects from conception through to completion, meeting schedules and budgets.

 

Work Conditions:

  • Employee is expected to follow all safety regulations, keep work area in a clean and orderly condition, and wear appropriate Personal Protective Equipment (PPE) as required for the assigned work area(s). Performs safety related duties as assigned.
  • Working conditions are normal for a manufacturing environment. Machinery operation requires the use of safety equipment to include not limited to safety glasses.

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